Creatine HCl Supplementation in Sarcopenia: A Randomized Controlled Study

NCT07285226 | Recruiting

• 1 other identifier: 4005-31-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The CONCRET-SARCOPA trial is a 12-week, double-blind, randomized controlled study designed to evaluate the efficacy of creatine HCl supplementation in older adults with sarcopenia. The trial investigates whether daily creatine HCl improves body composition, enhances functional muscle and cognitive performance, and favorably alters key blood biomarkers associated with muscle health and metabolic status. Additionally, the study assesses changes in tissue creatine levels using non-invasive and biochemical methods to clarify mechanistic responses to supplementation. Findings from this trial will provide critical evidence on the therapeutic potential of creatine HCl as a targeted nutritional strategy for managing sarcopenia in the geriatric population.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Hand-grip strength

  Handgrip strength quantifies maximal voluntary force generated by the hand using a dynamometer, serving as a simple, reliable indicator of overall muscle function and sarcopenia severity.

  Change from baseline hand-grip strength at 12 weeks

Secondary Outcomes (5)

• Senior fitness test score

  Change from baseline senior fitness test score at 12 weeks

• Mini-Mental State Examination Score

  Change from baseline Mini-Mental State Examination Score at 12 weeks

• Appendicular muscle mass

  Change from baseline appendicular muscle mass at 12 weeks

• Brain creatine

  Change from baseline brain creatine concentrations at 12 weeks

• Irisin

  Change from baseline serum levels of irisin at 12 weeks

Study Arms (2)

Experimental 1

EXPERIMENTAL

2 capsules of creatine HCl per day

Dietary Supplement: Experimental 1

Experimental 2

PLACEBO COMPARATOR

2 capsules of inulin HCl per day

Dietary Supplement: Experimental 2

Interventions

Experimental 1 DIETARY_SUPPLEMENT

Creatine HCl

Experimental 1

Experimental 2 DIETARY_SUPPLEMENT

Innulin (placebo)

Experimental 2

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 60 years
• Low muscle strength by handgrip (SDOC criteria for sarcopenia): \< 35.5 kg in men and \< 20 kg in women
• Sign free and informed consent
• Demonstrate interest, conditions and availability to participate

You may not qualify if:

• Patients undergoing interventional treatment for sarcopenia
• Physical amputation
• Cognitive impairment (MSSE \< 25)
• Unwillingness to return for follow-up analysis
• Participation in other clinical trials

Sponsors & Collaborators

• Center for Health Sciences, Serbia: lead

Study Sites (1)

Center for Health Sciences

Belgrade, 11000, Serbia

RECRUITING

Related Publications (3)

• Eghbali E, Arazi H, Suzuki K. Supplementing With Which Form of Creatine (Hydrochloride or Monohydrate) Alongside Resistance Training Can Have More Impacts on Anabolic/Catabolic Hormones, Strength and Body Composition? Physiol Res. 2024 Nov 15;73(5):739-753. doi: 10.33549/physiolres.935323.

  PMID: 39545789 BACKGROUND

• Korovljev D, Ostojic J, Panic J, Ranisavljev M, Todorovic N, Nedeljkovic D, Kuzmanovic J, Vranes M, Stajer V, Ostojic SM. The Effects of 8-Week Creatine Hydrochloride and Creatine Ethyl Ester Supplementation on Cognition, Clinical Outcomes, and Brain Creatine Levels in Perimenopausal and Menopausal Women (CONCRET-MENOPA): A Randomized Controlled Trial. J Am Nutr Assoc. 2026 Mar-Apr;45(3):199-210. doi: 10.1080/27697061.2025.2551184. Epub 2025 Aug 25.

  PMID: 40854087 BACKGROUND

• Tuckfield C. First use of creatine hydrochloride in premanifest Huntington disease. Med J Aust. 2015 Apr 20;202(7):378-80. doi: 10.5694/mja14.01070. No abstract available.

  PMID: 25877121 BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Sergej Ostojic, MD, PhD

  Center for Mitochondrial Medicine

  STUDY CHAIR

Central Study Contacts

Sergej Ostojic, MD, PhD

CONTACT

+381112643242; sergej.ostojic@chess.edu.rs

Nikola Todorovic

CONTACT

+381112643242; nikola.todorovic@appliedbioenergetics.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Data obtained through this study may be provided to qualified researchers with academic interest in perimenopause.

Locations

SE (1)